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Electroacupuncture as a Complement to Usual Care for Patients With Non-acute Pain After Back Surgery

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ClinicalTrials.gov Identifier: NCT01966250
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Byung-Cheul Shin, Korean Medicine Hospital of Pusan National University

Brief Summary:
The purpose of this study is to find out the effectiveness of integrative medicine model for pain relief and improvement of function and quality of life on the patients with pain after back surgery.

Condition or disease Intervention/treatment Phase
Low Back Pain Pain, Postoperative Failed Back Surgery Syndrome Device: electroacupuncture and usual care Device: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Electroacupuncture as a Complement to Usual Care for Patients With Non-acute Pain After Back Surgery: a Study Protocol for a Pilot Randomized Controlled Trial
Study Start Date : October 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Experimental: Electroacupuncture and Usual care
15 minutes of electroacupuncture and usual care. Usual care contains 15 minutes ICT(Interferential Current Therapy), 10 minutes hot pack or ice pack and education of patients.
Device: electroacupuncture and usual care

Electroacupuncture: Using 0.25 mm (diameter) X 0.40 mm (length) sized disposable stainless steel needles, electric stimulation will be applied with an electronic stimulator (ES-160, ITO co. LTD, Japan) 2 times/week × 4 weeks. Stimulation will be applied with the current in biphasic wave form. Acupuncture points are Jia-ji (Ex-B2, L3-L5; bilateral) as necessary points and reasonable points (according to decision of practitioner) as accessory points. Each session lasts 15 minutes.

Usual care: Physical therapy and patient education will be performed 2 times per week for 4 weeks. ICT lasts 15 minutes and Hot or Ice pack lasts 10minutes. Doctors will educate patient physiology, pathology, and epidemiology of low back pain. And also suitable postures and exercises for low back pain will be educated.


Active Comparator: usual care
15 minutes ICT, 10 minutes hot pack or ice pack and education of patients
Device: Usual care
Usual care: Physical therapy and patient education will be performed 2 times per week for 4 weeks. ICT lasts 15 minutes and Hot or Ice pack lasts 10minutes. Doctors will educate patient physiology, pathology, and epidemiology of low back pain. And also suitable postures and exercises for low back pain will be educated.




Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: up to 4 months ]

Secondary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: up to 4 months ]
  2. EuroQoL 5-Dimension Questionnaire [ Time Frame: up to 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients whose low back pain persisted or recurred after back surgery with or without leg pain.
  • Patients whose pain has been persisted at least 3 weeks recently and who are necessary to care intermittent medical treatments (eg. medication, injection, physio therapy).
  • Patients with pain, defined as an Visual Analogue Scale (VAS) value ≥ 50mm.
  • Patients who are 19 - 70 years of age.
  • Patients who agreed to voluntarily participate in this study and signed informed consent.

Exclusion Criteria:

  • Patients who have been diagnosed with a serious disease that can cause low back pain (e.g., cancer, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equine compression, or other disqualifying conditions).
  • Patients with progressive neurological deficit or severe neurological symptoms.
  • Patients whose pain causes are not resulted from spine or resulted from soft tissue diseases(e.g., cancer, fibromyalgia, rheumatoid arthritis, gout).
  • Patients with a chronic disease that could influences the effects of the treatment or the analysis of treatment results (e.g., cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, dementia, epilepsy, or other disqualifying conditions).
  • Patients for whom acupuncture would be inappropriate or unsafe (e.g., hemorrhagic disease, clotting disorders, a history of receiving anticoagulant therapy, severe diabetes with a risk of infection, severe cardiovascular disease, or other disqualifying conditions)
  • Patients who are currently pregnant or planning the pregnancy.
  • Patients with psychiatric diseases.
  • Patients who are participating in other clinical trial.
  • Patients who are unable to sign informed consent.
  • Patients who are judged to be inappropriate for the clinical study by the researchers, such as inability to read and write Korean.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966250


Locations
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Korea, Republic of
Pusan National University Korean Medicine Hospital
Yangsan, Gyeongsangnamdo, Korea, Republic of, 626-770
Sponsors and Collaborators
Korean Medicine Hospital of Pusan National University
Investigators
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Principal Investigator: Byung-cheul Shin Pusan National University Korean Medicine Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Byung-Cheul Shin, associate professor, Korean Medicine Hospital of Pusan National University
ClinicalTrials.gov Identifier: NCT01966250     History of Changes
Other Study ID Numbers: 2013012
K13273 ( Other Grant/Funding Number: Korea Institute of Oriental Medicine )
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain, Postoperative
Failed Back Surgery Syndrome
Pain
Neurologic Manifestations
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Complement System Proteins
Immunologic Factors
Physiological Effects of Drugs